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FDA takes first action under new international collaboration with Australia and Canada worldpharmanews
September 18, 2019
The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE).
FDA grants Fast Track designation for Farxiga in heart failure worldpharmanews
September 18, 2019
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death...
Gala Therapeutics Receives FDA Breakthrough Device Designation for RheOx™ americanpharmaceuticalreview
September 17, 2019
Gala Therapeutics announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (FDA) for the RheOx Bronchial Rheoplasty system.
Seattle Genetics, Astellas Announce FDA Grants Review for Enfortumab Vedotin BLA americanpharmaceuticalreview
September 17, 2019
Seattle Genetics and Astellas Pharma announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and ...
NDMA discovered in samples of ranitidine medicines europeanpharmaceuticalreview
September 17, 2019
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
FDA grants Orphan Drug Designation to sotatercept europeanpharmaceuticalreview
September 16, 2019
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
FDA grants regulatory approval for hypoglycemia treatment europeanpharmaceuticalreview
September 16, 2019
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
FDA emphasises need for adverse event reporting of compounded drugs europeanpharmaceuticalreview
September 16, 2019
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
United Therapeutics Announces FDA Acceptance of Trevyent New Drug Application For Review drugs
September 16, 2019
United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary...
Intra-Cellular Therapies Provides Lumateperone Regulatory Update drugs
September 16, 2019
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders ...

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